Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-31 @ 11:58 AM
Study NCT ID:
NCT04541251
Status:
UNKNOWN
Last Update Posted:
2021-06-23
First Post:
2020-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Stage IB-IIIA NSCLC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000631724', 'term': 'camrelizumab'}, {'id': 'C520255', 'term': '130-nm albumin-bound paclitaxel'}, {'id': 'D016190', 'term': 'Carboplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2020-02-09', 'studyFirstSubmitQcDate': '2020-09-04', 'lastUpdatePostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Major pathologic response (MPR) Rate', 'timeFrame': 'After surgery (approximately 10 weeks)', 'description': 'MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of the pathological complete response (pCR)', 'timeFrame': 'After surgery (approximately 10 weeks)', 'description': 'pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy.'}, {'measure': 'Evaluation of complete resection (R0) rate', 'timeFrame': 'After surgery (approximately 10 weeks)', 'description': 'Proportion of patients with no residual resection margin under the microscope after tumor resection'}, {'measure': 'Disease free survival (DFS)', 'timeFrame': '36 months', 'description': 'From the date of surgery to any of the following events: disease progression, disease recurrence or death from any cause.'}, {'measure': 'Overall survival (OS)', 'timeFrame': '36 months', 'description': 'From the date of participated in study to the date of death.'}, {'measure': 'Objective response rate(ORR)', 'timeFrame': 'approximately 9 weeks', 'description': 'The proportion of patients achieved complete or patial remission(Imageological) according to RECIST 1.1 prior to definitive surgery'}, {'measure': 'Adverse events (AEs)', 'timeFrame': 'approximately 9 weeks', 'description': 'The number of participants experiencing an AE will be assessed.An AE is defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy can be determined'}, {'measure': 'Serious adverse events (SAEs)', 'timeFrame': 'approximately 9 weeks', 'description': 'The number of participants experiencing an serious AE will be assessed'}, {'measure': 'Qol Quality of Life', 'timeFrame': '36 months', 'description': 'Quality of life asscesed by Quality of Life Questionnare-Core 30(EORTC QLQ-C30）of The European O-rganization for Reasearch and Functional Assessment of Cancer Therapy-Lung (FACT-L)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer', 'Neoadjuvant therapy', 'Immune checkpoint inhibitor', 'Major pathological response', 'Artificial intelligence'], 'conditions': ['Lung Cancer, Non-small Cell', 'Artificial Intelligence']}, 'referencesModule': {'references': [{'pmid': '34992825', 'type': 'DERIVED', 'citation': 'Zhou H, Lin L, Qin T, Ren W, Tan Y, Yang Q, Xu H, Xie X, Chen Y, Liu S, Li X, Li Z, Hu H, Yu Y, Yao H. Neoadjuvant camrelizumab, nab-paclitaxel, and carboplatin in patients with stage IB-IIIA non-small cell lung cancer (NANE-LC): a study protocol of prospective, single-arm, multicenter, phase II study. J Thorac Dis. 2021 Nov;13(11):6468-6475. doi: 10.21037/jtd-21-1022.'}]}, 'descriptionModule': {'briefSummary': 'This prospective, single-arm, multicenter, phase II trial enrolled 40 patients who underwent surgery after three cycles of neoadjuvant therapy with camrelizumab, nab-paclitaxel, and carboplatin. The MPR is the primary endpoint, and the pCR, the complete resection rate, the objective response rate, the disease-free survival, adverse events, and quality of life are the secondary endpoints. The exploratory endpoints will be used to establish a multiomics artificial intelligence system for neoadjuvant therapy effect prediction and decision-making assistance based on radiomics, metabolism, genetic, and clinic-pathological characteristics and to explore drug resistance mechanisms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* The patients have stage IB-IIIA NSCLC.\n* Patient ages are ≥ 18 years old, regardless of gender.\n* The patients have an ECOG ps of 0-1, with a condition suitable for surgery.\n* The patients have not received any anti-tumor treatment.\n* The patients have adequate blood function.\n* The patients have adequate organ function.\n* The patients had been using an appropriate method of contraception, and there exists a negative pregnancy test (serum or urine) for women.\n* The patients will give their signed informed consent.\n\nExclusion criteria:\n\n* Patients who had a prior allogeneic tissue or organ transplantation.\n* Patients who have multiple cancers.\n* Patients who have any severe or uncontrolled systemic diseases.\n* Patients with a positive test for HIV, HBV, or HCV.\n* Patients with severe infection or with an infection that required antibiotic therapy.\n* Patients with a history of interstitial lung disease, active tuberculosis, or autoimmune disease.\n* Patients who have participated in any other clinical trials.\n* Patients who are considered ineligible by the investigator.'}, 'identificationModule': {'nctId': 'NCT04541251', 'briefTitle': 'Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Stage IB-IIIA NSCLC', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}, 'officialTitle': 'Neoadjuvant Camrelizumab, Nab-paclitaxel and Carboplatin in Patients With Stage IB-IIIA Non-small Cell Lung Cancer (NANE-LC): A Prospective, Single-arm, Multicenter, Phase II Study', 'orgStudyIdInfo': {'id': '2020-KY-061-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Camrelizumab + Nab-paclitaxel + Carboplatin', 'interventionNames': ['Drug: Camrelizumab + Nab-paclitaxel + Carboplatin']}], 'interventions': [{'name': 'Camrelizumab + Nab-paclitaxel + Carboplatin', 'type': 'DRUG', 'description': 'The patients will receive three cycles (one cycle is defined as every 21 days +/- 3 days) of neoadjuvant therapy with camrelizumab 200 mg, nab-paclitaxel 260 mg/m2, and carboplatin AUC 5. This will then be followed by surgery.', 'armGroupLabels': ['Camrelizumab + Nab-paclitaxel + Carboplatin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510120', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Herui Yao, PhD', 'role': 'CONTACT', 'email': 'yaoherui@mail.sysu.edu.cn', 'phone': '+8618218018525'}, {'name': 'Yunfang Yu, MD', 'role': 'CONTACT', 'email': 'yuyf9@mail.sysu.edu.cn', 'phone': '+8618218018525'}], 'facility': 'Sun Yat-Sen Memorial Hospital of Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Herui Yao, PhD', 'role': 'CONTACT', 'email': 'yaoherui@mail.sysu.edu.cn', 'phone': '18218018525'}, {'name': 'Yunfang Yu, MD', 'role': 'CONTACT', 'email': 'yuyf9@mail.sysu.edu.cn'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, 'collaborators': [{'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Herui Yao', 'investigatorAffiliation': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University'}}}}